Pfizer will discontinue development of danuglipron, an oral glucagon-like peptide-1 (GLP-1) receptor agonist, which was being investigated for chronic weight management.
The decision comes after a single participant in one of the dose-optimization studies experienced a potential drug-induced liver injury which resolved after discontinuation of danuglipron. According to Pfizer, after reviewing all clinical data generated to date for danuglipron and recent input from regulators, the company has decided to discontinue development of the molecule.
The once-daily tablet formulation of danuglipron, tested in twp phase 1 dose-optimization studies, had met key pharmacokinetic objectives and confirmed a formulation and dose with the potential to deliver a competitive efficacy and tolerability profile in phase 3 testing, based on earlier studies of twice-daily danuglipron.
In December 2023, Pfizer decided that the twice-daily danuglipron formulation would not advance into phase 3 studies after the phase 2 trial had discontinuation rates greater than 50%, with patients experiencing nausea, vomiting and diarrhea.